ibuprofen infants

Generic: ibuprofen

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen infants
Generic Name ibuprofen
Labeler h e b
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-057
Product ID 37808-057_b2cfae91-2360-445e-9933-78793d3b8854
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075217
Listing Expiration 2026-12-31
Marketing Start 2002-06-18

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808057
Hyphenated Format 37808-057

Supplemental Identifiers

RxCUI
204442
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ibuprofen infants (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA075217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (37808-057-05) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

37808-057-05 1 BOTTLE in 1 CARTON (37808-057-05) / 15 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

ibuprofen infants ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b2cfae91-2360-445e-9933-78793d3b8854", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["e353bc69-c03e-4bae-a357-f7f3fab91695"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-057-05)  / 15 mL in 1 BOTTLE", "package_ndc": "37808-057-05", "marketing_start_date": "20020618"}], "brand_name": "ibuprofen infants", "product_id": "37808-057_b2cfae91-2360-445e-9933-78793d3b8854", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "37808-057", "generic_name": "ibuprofen", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ibuprofen", "brand_name_suffix": "infants", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA075217", "marketing_category": "ANDA", "marketing_start_date": "20020618", "listing_expiration_date": "20261231"}